Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers (HODFU)

Mrs. Thelma Zoegas Foundation

Status and phase: Completed; Phase 4

Conditions: Diabetes; Foot Ulcer; Healing

Treatments: Device: hyperbaric air; Device: HBOT

Study type: Interventional

Funder types: Other

Identifiers

NCT00953186

Z012094

Details and patient eligibility

About

The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes mellitus,
• foot ulcer with duration > 3 months,
• treatment at Diabetes foot clinic for > 2 months,
• vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion criteria

• severe obstructive pulmonary disease,
• malignancy and untreated thyrotoxicosis),
• current drug or alcohol misuse,
• vascular surgery in the lower limbs within the last two months,
• participation in another study or suspected poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

HBOT

Active Comparator group

Description:

100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks

Treatment:

Device: HBOT

Placebo

Placebo Comparator group

Description:

air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks

Treatment:

Device: hyperbaric air